| CTRI Number |
CTRI/2023/06/054507 [Registered on: 27/06/2023] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Trial to evaluate the effectiveness of Thoothuvalai Nei in the treatment of Eraippu Noi (Childhood Bronchial Asthma) in Children |
|
Scientific Title of Study
|
An Open Single Arm Single Centric Phase-II Clinical Trial to evaluate the effectiveness of Thoothuvalai Nei in the treatment of Eraippu Noi (Childhood Bronchial Asthma) in Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Suvedha |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8148888967 |
| Fax |
|
| Email |
suvevas95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A M Amala Hazel |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9486909809 |
| Fax |
|
| Email |
dramalaaruldhas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A M Amala Hazel |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9486909809 |
| Fax |
|
| Email |
dramalaaruldhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha, Chennai |
|
|
Primary Sponsor
|
| Name |
Ayothidoss Pandithar Hospital, National Institute of Siddha |
| Address |
Room No 17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Suvedha |
Ayothidoss Pandithar Hospital |
Room No 17, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai
Kancheepuram
TAMIL NADU |
8148888967
suvevas95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, (2) ICD-10 Condition: J453||Mild persistent asthma, (3) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Thoothuvalai Nei |
5 ml for 5 to 7 years,
8 ml for 8 to 12 years,
Once a day in the morning after food for 45 days
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of both sex in the age group of 5 to 12 years with any two or more following symptoms of Cough, Wheezing, Dyspnea, Tightness of chest, Shortness of breath 2.Symptoms of Bronchial Asthma along with Peak Expiratory Flow Rate more than 50% (mild, moderate) 3.Patient informant / parent willing to sign the informed consent form |
|
| ExclusionCriteria |
| Details |
1. Hemoptysis
2. Pneumonia
3. Status Asthmaticus
4. Congenital heart diseases
5. Peak expiratory flow rate less than 50%(severe exacerbation) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome will be assessed using Peak Expiratory Flow Meter & PASS Score
|
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/07/2023 |
| Date of Study Completion (India) |
31/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION: This is an Open Single Arm Single Centric Phase II Clinical Trial to Evaluate the Effectiveness of Thoothuvalai Nei in the Treatment of Eraippu Noi (Childhood Bronchial Asthma) in Children. Eraippu Noi is otherwise called Ezhuppu Noi or Swasakasam. Eraippu Noi is characterized by the tightness of the chest, difficulty in breathing in which expiratory breathing sound resembles the sounds of musical instruments like flute, loot or veena, presence of cold with or without expectoration during cough according to the Pediatric Siddha textbook Pillaippini Maruthuvam. MATERIALS AND METHODS: In an Open Single Arm Single Centric Phase II Clinical Trial, children within the age limit of 5-12 years will be enrolled based on inclusion and exclusion criteria after signing the consent form by the parent /Guardian and assent form by the children. After enrolment, the trial drug Thoothuvalai Nei (Dosage : 5 ml for 5 - 7 years, 8 ml for 8 – 12 years) will be given once a day in the morning after food for 45 days. DATA ANALYSIS: The data will be analyzed using the statistical analysis method. OUTCOME: The outcome will be assessed using Peak Expiratory Flow Meter and PASS Score.
|